Sklar®
Censitrac Ready Plast Surg Retr Flex BL 2PR 6 Inches
34manufacturers in China registered for this device type
753catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Showing 12 of 34. All 34 manufacturers in China registered for Retractor
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-29 |
| Record revised | 2020-09-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60-1951 | In distribution | ||
| 60-1907 | In distribution | ||
| 41-1408 | In distribution | ||
| 41-1462 | In distribution | ||
| 40-8235 | In distribution | ||
| 60-1885 | In distribution | ||
| 60-2110 | In distribution | ||
| 60-1945 | In distribution | ||
| 57-1465 | In distribution | ||
| 60-2039 | In distribution | ||
| 60-3113C | In distribution | ||
| 60-4312 | In distribution | ||
| 60-3625C | In distribution | ||
| 60-7229 | In distribution | ||
| 78-1002 | In distribution | ||
| 60-6660 | In distribution | ||
| 41-1461 | In distribution | ||
| 60-6062 | In distribution | ||
| 41-1383 | In distribution | ||
| 60-8813 | In distribution | ||
| 60-6281 | In distribution | ||
| 22-8565 | In distribution | ||
| 60-1941 | In distribution | ||
| 47-2607 | In distribution | ||
| 60-1643 | In distribution | ||
| 50-1272 | In distribution | ||
| 60-1722 | In distribution | ||
| 50-1273 | In distribution | ||
| 60-8105 | In distribution | ||
| 41-1404 | In distribution | ||
| 41-1397 | In distribution | ||
| 60-4246 | In distribution | ||
| 60-5504 | In distribution | ||
| 60-4314 | In distribution | ||
| 60-7400 | In distribution | ||
| 60-4306 | In distribution | ||
| 60-1691C | In distribution | ||
| 60-2812 | In distribution | ||
| 55-7481 | In distribution | ||
| 60-5612 | In distribution | ||
| 47-6001 | In distribution | ||
| 22-9124 | In distribution | ||
| 60-3615C | In distribution | ||
| 40-8280 | In distribution | ||
| 60-1695C | 2 | In distribution | |
| 60-1893 | In distribution | ||
| 60-2172 | In distribution | ||
| 60-7411 | In distribution | ||
| 60-5506 | In distribution | ||
| 60-7410 | In distribution | ||
| 60-6158 | In distribution | ||
| 60-5821C | In distribution | ||
| 60-9103 | In distribution | ||
| 60-2178 | In distribution | ||
| 60-7231 | In distribution | ||
| 60-8814 | In distribution | ||
| 50-1277 | In distribution | ||
| 33-1720 | In distribution | ||
| 60-6089 | In distribution | ||
| 60-3113 | In distribution | ||
| 47-2516 | In distribution | ||
| 47-2655C | In distribution | ||
| 60-3090 | In distribution | ||
| 22-9113 | In distribution | ||
| 22-7795 | In distribution | ||
| 60-2162 | In distribution | ||
| 60-2053 | In distribution | ||
| 40-7740 | In distribution | ||
| 60-8812 | In distribution | ||
| 55-7482 | In distribution | ||
| 60-8051 | In distribution | ||
| 60-7418 | In distribution | ||
| 47-2605 | In distribution | ||
| 40-8240 | In distribution | ||
| 55-7204 | In distribution | ||
| 47-2616 | In distribution | ||
| 41-1465 | In distribution | ||
| 60-1716 | In distribution | ||
| 60-8103 | In distribution | ||
| 60-1674 | In distribution | ||
| 47-2612 | In distribution | ||
| 60-3630 | In distribution | ||
| 60-1966 | In distribution | ||
| 60-1075 | In distribution | ||
| 60-3617C | In distribution | ||
| 55-7210 | In distribution | ||
| 60-1894 | In distribution | ||
| 47-2601 | In distribution | ||
| 55-7153 | In distribution | ||
| 50-1316 | In distribution | ||
| 22-8214 | In distribution | ||
| 60-6662 | In distribution | ||
| 60-3607 | In distribution | ||
| 60-3412C | In distribution | ||
| 78-1103 | In distribution | ||
| 60-2191 | In distribution | ||
| 60-4416 | In distribution | ||
| 60-1904 | In distribution | ||
| 60-7221 | In distribution | ||
| 47-2603 | In distribution | ||
| 60-7425 | In distribution | ||
| 50-1325 | In distribution | ||
| 60-2190 | In distribution | ||
| 60-5435 | In distribution | ||
| 60-5623 | In distribution | ||
| 40-8238C | In distribution | ||
| 60-7222 | In distribution | ||
| 60-4253 | In distribution | ||
| 60-5506C | In distribution | ||
| 78-1201 | In distribution | ||
| 78-1113 | In distribution | ||
| 55-7220 | In distribution | ||
| 60-3090C | In distribution | ||
| 55-7200 | In distribution | ||
| 60-7428 | In distribution | ||
| 41-1382 | In distribution | ||
| 60-1350 | 2 | In distribution | |
| 60-2073 | In distribution | ||
| 60-5434 | In distribution | ||
| 60-8815 | In distribution | ||
| 78-1104 | In distribution | ||
| 65-1847 | In distribution | ||
| 55-7141 | In distribution | ||
| 60-1794 | In distribution | ||
| 60-7233 | In distribution | ||
| 60-1714 | In distribution | ||
| 40-7446 | In distribution | ||
| 60-1785 | In distribution | ||
| 60-3630C | In distribution | ||
| 60-7421 | In distribution | ||
| 60-7429 | In distribution | ||
| 60-7440 | In distribution | ||
| 47-2610 | In distribution | ||
| 60-2030 | In distribution | ||
| 60-2011 | In distribution | ||
| 78-1203 | In distribution | ||
| 60-1642 | In distribution | ||
| 60-2712 | In distribution | ||
| 52-1277C | In distribution | ||
| 41-1454 | In distribution | ||
| 22-8860C | In distribution | ||
| 60-1461 | 2 | In distribution | |
| 60-2197 | In distribution | ||
| 60-3312C | In distribution | ||
| 60-5813 | In distribution | ||
| 60-6260 | In distribution | ||
| 47-2545 | In distribution | ||
| 50-1301 | In distribution | ||
| 60-6164C | In distribution | ||
| 60-1101 | In distribution | ||
| 55-7483 | In distribution | ||
| 47-2615 | In distribution | ||
| 55-7195C | In distribution | ||
| 40-8222 | In distribution | ||
| 60-3594 | In distribution | ||
| 60-4243C | In distribution | ||
| 60-1085 | 2 | In distribution | |
| 40-8220 | In distribution | ||
| 57-1448 | In distribution | ||
| 60-8102 | In distribution | ||
| 60-7150 | In distribution | ||
| 60-7430 | In distribution | ||
| 22-9122 | In distribution | ||
| 60-2181 | In distribution | ||
| 42-1470 | In distribution | ||
| 40-7742 | In distribution | ||
| 50-1290 | In distribution | ||
| 60-5604C | In distribution | ||
| 60-6111 | In distribution | ||
| 22-9123 | In distribution | ||
| 60-7225 | In distribution | ||
| 60-9102 | In distribution | ||
| 55-7125 | In distribution | ||
| 55-7142 | In distribution | ||
| 60-7441 | In distribution | ||
| 50-1276 | In distribution | ||
| 55-7151 | In distribution | ||
| 42-2126 | In distribution | ||
| 60-7220 | In distribution | ||
| 22-9132 | In distribution | ||
| 55-7480 | In distribution | ||
| 40-9281 | In distribution | ||
| 47-2604 | In distribution | ||
| 50-1306 | In distribution | ||
| 60-3629 | In distribution | ||
| 60-7420 | In distribution | ||
| 60-4404 | In distribution | ||
| 60-1104 | In distribution | ||
| 60-1100C | 3 | In distribution | |
| 57-1487 | In distribution | ||
| 42-2107 | In distribution | ||
| 60-1783 | In distribution | ||
| 60-2183 | In distribution | ||
| 60-5431 | In distribution | ||
| 60-5816 | In distribution | ||
| 60-6162C | In distribution | ||
| 60-7416 | In distribution | ||
| 60-6168 | In distribution | ||
| 60-2182 | In distribution | ||
| 22-8213C | In distribution | ||
| 40-8175 | In distribution | ||
| 22-7855 | In distribution | ||
| 60-1695 | 2 | In distribution | |
| 41-1463 | In distribution | ||
| 60-2185 | In distribution | ||
| 60-7423 | In distribution | ||
| 42-1824 | In distribution | ||
| 60-1870 | In distribution | ||
| 78-1101 | In distribution | ||
| 47-2602 | In distribution | ||
| 42-1822 | In distribution | ||
| 60-5826 | In distribution | ||
| 50-1344 | In distribution | ||
| 60-7415 | In distribution | ||
| 60-8835 | In distribution | ||
| 55-4113 | In distribution | ||
| 60-2174 | In distribution | ||
| 60-7310 | In distribution | ||
| 50-1324 | In distribution | ||
| 60-1656C | In distribution | ||
| 57-1481 | In distribution | ||
| 47-2613 | In distribution | ||
| 40-8285 | In distribution | ||
| 60-2712C | In distribution | ||
| 33-1723 | In distribution | ||
| 22-8086 | In distribution | ||
| 42-1464 | In distribution | ||
| 60-2390 | In distribution | ||
| 60-4253C | In distribution | ||
| 60-7442 | In distribution | ||
| 57-1488 | In distribution | ||
| 60-1087 | In distribution | ||
| 60-5830 | In distribution | ||
| 60-4304 | In distribution | ||
| 60-1671C | In distribution | ||
| 60-1666C | In distribution | ||
| 50-1304 | In distribution | ||
| 60-3617 | In distribution | ||
| 60-6371 | In distribution | ||
| 60-1793 | In distribution | ||
| 57-1489 | In distribution | ||
| 41-1435 | In distribution | ||
| 60-7321 | In distribution | ||
| 40-8231 | In distribution | ||
| 50-1278 | In distribution | ||
| 60-8100 | In distribution | ||
| 60-6101 | In distribution | ||
| 60-7227 | In distribution | ||
| 42-2121 | In distribution | ||
| 55-7211 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thompson | Thompson Surgical Instruments, Inc. | 4,354 |
| Millennium | Avalign Technologies, Inc. | 2,128 |
| Surtex | Surtex Instruments Ltd | 1,318 |
| Life Instruments | Life Instrument Corp. | 1,135 |
| Innomed, Inc. | Innomed, Inc. | 1,017 |
| Aesculap | Aesculap AG | 1,013 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 973 |
| Elmed | Elmed, Inc. | 919 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 891 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Ambler Surgical | Ambler Surgical, LLC | 744 |
Showing 12 of 2,238. All products under Retractor
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 1050 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.